NCT01327508

Brief Summary

The objective of this study is to quantitate the amount of radiation both subjects and surgeons are exposed to during intramedullary nailing of the femur using the TRIGEN SURESHOT Distal Targeting System versus Standard nailing instrumentation.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
2 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

February 9, 2016

Completed
Last Updated

March 14, 2018

Status Verified

February 1, 2018

Enrollment Period

1.8 years

First QC Date

March 30, 2011

Results QC Date

June 6, 2014

Last Update Submit

February 14, 2018

Conditions

Femoral Shaft Fracture

Outcome Measures

Primary Outcomes (1)

  • Radiation Exposure Measurement

    Radiation exposure measured in two ways: Whole body badge TLD ring badge

    Intraoperative

Secondary Outcomes (1)

  • Distal Locking Time

    Intraoperative

Study Arms (2)

TRIGEN SURESHOT Distal Targeting

EXPERIMENTAL

TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.

Device: TRIGEN SURESHOT Distal Targeting Instrumentation.

Standard Nailing Instrumentation.

ACTIVE COMPARATOR

Free-hand technique utilizes x-rays to find screw holes

Other: Free-hand technique

Interventions

TRIGEN SURESHOT Distal Targeting Instrumentation.DEVICE

image-guided localization system

Also known as: SURESHOT
TRIGEN SURESHOT Distal Targeting
Free-hand techniqueOTHER

Free-hand technique utilizes x-rays to find screw holes.

Standard Nailing Instrumentation.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral femoral shaft fracture requiring intramedullary nailing in which the use of stereotactic surgery may be appropriate.
  • Subject is between 18-80 years of age.
  • Subject is skeletally mature
  • Subject is of legal age and capable of providing legal consent.
  • Subject is suitable for current Intramedullary Nailing procedure
  • Subject willing to accept randomization either to the TRIGEN SURESHOT Distal Targeting System or TRIGEN standard instrumentation.

You may not qualify if:

  • Femur shaft fracture not amenable to intramedullary nailing in which the use of sterotactic surgery may be inappropriate.
  • Fracture with vascular injury (Gustilo Type IIIC) requiring repair
  • Open fractures where open wound is in communication with distal targeting holes and therefore would influence duration of locking procedure (i.e. potentially no need for incisions for locking screw placement).
  • Fracture of the Metaphyseal distal femur with intraarticular comminution
  • Known Pathological Fracture
  • Subject is a prisoner
  • Operative procedure for closed fracture is scheduled for greater than 2 weeks for closed fractures
  • Subject has cognitive issue/mental status conditions that preclude intramedullary nailing in the judgment of the investigator.
  • Contralateral femoral shaft fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Department of Orthopaedics and Rehabilitation

Gainesville, Florida, 32607, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Duke University Medical Center

Durham, North Carolina, 27707, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University Hospital Trauma Service

San Antonio, Texas, 78229, United States

Location

Capital District Health Authority

Halifax, Nova Scotia, Canada

Location

Results Point of Contact

Title
Cathy Newbill
Organization
Smith & Nephew, Inc.
cathy.newbill@smith-nephew.com
800-821-5700

Study Officials

  • Samir Mehta, M.D.

    Orthopaedic Surgery, Hospital of the University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Animesh Agarwal, M.D.

    UT Health Science Center, Dept of Orthopaedic

    PRINCIPAL INVESTIGATOR

  • Marcus Sciadini, M.D

    University of Maryland Baltimore, Department of Orthopaedics

    PRINCIPAL INVESTIGATOR

  • Steven Olson, M.D.

    Duke University Medical Center of Orthopaedic

    PRINCIPAL INVESTIGATOR

  • Chad Coles, M.D.

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

  • Richard Vlasak, M.D.

    Dept. of Orthopaedics & Rehab University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 1, 2011

Study Start

April 1, 2011

Primary Completion

January 1, 2013

Study Completion

June 1, 2013

Last Updated

March 14, 2018

Results First Posted

February 9, 2016

Record last verified: 2018-02

Locations

CA(1)US(6)